RD Systems_SSJ - REDACTED.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

NIOSH/HELD/ACIB

1095 Willowdale Road Mail Stop: 4020 Morgantown, WV 26505

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Acquisition Services Acquisition Branch #3, Section 4

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Acquisition of plates for profiling of immune biomarkers in genetically modified murine samples.

b. Procurement Request (PR) Number (if available):

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: R&D Biotechne (R&D Systems), 614 McKinley Place NE, Minneapolis, MN, 55413

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number:

D. Justification:

Rev. 5/14/19

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency Exclusive licensing agreements/Proprietary data Brand name required Industrial mobilization Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency Only One Source Logical Follow Up Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The CDC’s Office of Acquisition Services, on behalf of the National Institute for Occupational Safety and Health / Health Effects Laboratory Division / Allergy and Clinical Immunology Branch (ACIB) has a requirement to contract for plates and reagents for use with Luminex xMap technology plate reader to simultaneously quantify 13 analytes in low volume murine serum samples. The required analytes are Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL- 1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha. The ACIB requires assays that are compatible with Luminex xMAP technology to be read on the available plate reader, for direct comparison to prior data collected in the lab, and to ensure data reproducibility and reduce animal usage. The analytes must be quantified simultaneously due to a low volume of sample, as there is not enough volume to perform multiple quantifications. The required assay kits must be customizable to analyze immune responses to fungal exposure over time.

The ACIB requires Luminex xMAP technology as it is capable of precisely measuring multiple analytes simultaneously in a small volume of one sample. The color-coded bead-based assays use internally dyed beads that correspond to a distinct spectral signature from which bead-bound antibodies specific to target analytes can be detected and quantified. Other technologies are not able to quantify at such high levels of precision, reliability, and reproducibility.

The ACIB requires customizable assay kits to be utilized in its scientific research to examine cellular and molecular changes in the murine immune environment following repeated fungal exposures over time using genetically modified mice and requires the capability to simultaneously quantify Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha from a murine blood serum sample. The data acquisition, methodology, and analysis are a crucial component to the ACIB’s scientific research and will allow for the determination of the impact of fungal exposure on the pulmonary health effects. Cytokine analysis resultant from this research will allow for the comparison between previously studied fungal exposures in relevant genetic backgrounds of animals. In current studies, cytokines will be quantified from low volume murine blood serum samples over a period of recovery following exposure, to determine if the immune profile changes over time, and correlated to serum antibody levels and other immunoassay results.

Luminex xMAP technology and complex cytokine quantification assays have been used for several prior studies, and to ensure study reliability and reproducibility, the same technology and parallel analytes must be utilized.

R&D Systems is the only source reasonably available in accordance with FAR 13.106-1(b)(1) to meet the ACIB’s requirements. R&D Systems possesses unique technology that delivers high performance, precision, and reproducibility through the use of Luminex xMAP technology. R&D Systems offers the Luminex xMAP technology that is utilized in Luminex assays to precisely measure multiple analytes simultaneously in one sample. The color-coded bead-based assays use internally dyed beads that correspond to a distinct spectral signature from which bead-bound antibodies specific to target analytes can be detected and quantified. For the ACIB’s current study, a specific set of thirteen analytes is required for simultaneous quantification: Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha. R&D Systems is capable of providing customizable assay kits for which the ACIB can build an assay that simultaneously quantifies all 13 analytes (Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL- 10, IL-13, IL-17A, IL-33, and TNFalpha) in a single low volume sample for ongoing murine immunology studies. Additionally, because the R&D Systems product will enable the ACIB to simultaneously quantify the required 13 analytes in the murine serum samples, the need for redundant assays and sample waste will be reduced and will allow for direct comparison of the data to prior published studies to ensure data reproducibility. R&D Systems is the only company that offers this product. The specificity of analytes and reproducibility of prior assays is not offered using other products. Additionally, these assays undergo multiple quality control steps to ensure long-term reproducibility and consistency and requires only a small sample volume. These assays have been optimized and validated for optimal performance.

R&D Systems offer a wide range of targets from which panels are either pre-developed or can be generated based on needs. The antibodies used are specific to each target and have been confirmed to have little cross-over, which limits variability between assays. The specificity and reproducibility of this assay is not offered using other products. These assays have been previously used by the ACIB laboratory and are only available through R&D Systems. These assays were previously used to examine specific targets of interest in patient sera and provided accurate quantification and reproducible results. Based on the high specificity and reproducibility of the Luminex xMAP technology, as well as the requirement for reproducibility of previous datasets, R&D Systems is the only company that can offer this product.

b. What other products/services were considered and why did they not meet the need?

A google internet search was utilized to identify potential suppliers of Luminex xMap assays with the required 13 analytes: Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha. After limited results were identified, the search was expanded to include companies that supply Luminex xMap assays. This search identified R&D Biotechne, MilliporeSigma, and BioRad as potential options. R&D Biotechne is capable and available to provide this product. R&D Biotechne has customizable assay kits for which the ACIB can build a single assay that simultaneously quantifies all 13 analytes:

Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha in a single low volume sample. MilliporeSigma possesses Luminex xMap technology but does not offer reagents for all 13 required analytes. The available kits lack CXCL13 and IL-33. BioRad possesses Luminex Xmap technology, but their assays do not offer all 13 required analytes. Additionally, of the analytes they do offer, they are on separate kits and cannot be combined into one, therefore more than one assay per sample would need to be performed and would still not quantify all thirteen analytes, which does not meet the requirement. The use of this supplier would result in increased cost as a greater of quantity assays would need to be purchased to quantify the available analytes, but still not all thirteen required.

3. Program Office efforts to seek potential offerors:

The ACIB conducted an internet search for vendors that offer serum biomarker profiling that can accurately perform quantification of Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL- 1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha simultaneously, and at a highly reproducible level using the Luminex xMAP technology, as well as cost effective product that delivers reproducibility to previously collected datasets. Only R&D Systems’ Luminex assay products met all our requirements.

Other vendors offering serum biomarker profiling were considered; however, no other vendor offers R&D System's Luminex xMAP technology and level of customization, as well as analyte specificity. All 13 analytes (Eotaxin, CXCL13, GM-CSF, interferon-gamma, IL-1beta, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17A, IL-33, and TNFalpha) are required for the ACIB’s scientific research, and other vendors are unable to supply single assay kits with all 13 analytes included. Additionally, these assays have been used by the ACIB in previous research studies, and data must be compared to prior studies to ensure reproducibility. Use of other technologies would prevent direct comparison to previously published results. Use of multiple overlapping assays would necessitate additional animal exposures and use, which should be avoided if possible. Use of an assay lacking analytes would reduce data utility and, depending on the analytes removed, reduce ability to compare to prior studies. While other companies do make Luminex assays, none are customizable like the assays from R&D Systems. R&D Systems’s customizable assays allow for the Program to select the specific analytes needed, rather than necessitating the purchase of multiple overlapping assays. Therefore, and in accordance with FAR 13.106-1(b)(1), R&D Systems is the only source reasonably available to meet the ACIB’s requirements for customizable assay kits that are compatible with Luminex xMAP technology that can simultaneously quantify the required 13 analytes in low volume murine serum samples to the delivery of high performance, precision, reliability, and reproducibility.